Ethical Issues in Clinical Research: A Practical Guide

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Overview

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

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Editorial Reviews

Doody's Review Service
Reviewer: Vincent F Carr, DO, MSA, FACC, FACP (Uniformed Services University of the Health Sciences)
Description: This book describes the fundamental understanding researchers must have prior to embarking on clinical research studies. While it includes the concepts of the Code of Federal Regulations "Common Rule," it also has very practical examples of how to apply that information.
Purpose: This is the basis of a course the author has designed for postdoctoral fellows beginning their research careers. Because of a number of unfortunate cases over the previous decades, this is a necessary topic for discussion.
Audience: As this book serves as the basis of a course, it is clearly directed at those with a beginning knowledge of the subjects. It is essentially based upon the Common Rule as promulgated in the Code of Federal Regulations.
Features: Each section covers the basics, such as "What research is subject to the Common Rule?" and informed consent, but also includes case studies exemplifying the practical application of the regulations. The book is highly focused on the Common Rule, which is the foundation for the ethical principles of research. However, there are a number of other aspects that have ethical implications that are not considered with the Common Rule and should be discussed, e.g. the role of scientific review boards to determine if the research has reasonable scientific value in order to avoid risks, psychological or financial, when there is little to be gained from the research or the research is significantly duplicative in nature. There is also the consideration of "dual-use" research when biological, infectious disease, or biochemical research could be used to harm and whether that research should be performed or even published. The sections on historical perspectives and fetal stem cells approach these types of issues, but further expansion of these topics would be appropriate to distinguish this book from others in this area.
Assessment: This is an interesting read with illustrative cases that is suitable as a guide for a college-level course. However, it should be considered a starting point for ethics discussions. It does not address some of the chronically vexing problems such as the scientific merit of some studies or studies that do not prove what the investigator wanted so they are not published. There are many ethical questions that this book does not cover.
From The Critics
Reviewer: Vincent F Carr, DO, MSA, FACC, FACP(Uniformed Services University of the Health Sciences)
Description: This book describes the fundamental understanding researchers must have prior to embarking on clinical research studies. While it includes the concepts of the Code of Federal Regulations "Common Rule," it also has very practical examples of how to apply that information.
Purpose: This is the basis of a course the author has designed for postdoctoral fellows beginning their research careers. Because of a number of unfortunate cases over the previous decades, this is a necessary topic for discussion.
Audience: As this book serves as the basis of a course, it is clearly directed at those with a beginning knowledge of the subjects. It is essentially based upon the Common Rule as promulgated in the Code of Federal Regulations.
Features: Each section covers the basics, such as "What research is subject to the Common Rule?" and informed consent, but also includes case studies exemplifying the practical application of the regulations. The book is highly focused on the Common Rule, which is the foundation for the ethical principles of research. However, there are a number of other aspects that have ethical implications that are not considered with the Common Rule and should be discussed, e.g. the role of scientific review boards to determine if the research has reasonable scientific value in order to avoid risks, psychological or financial, when there is little to be gained from the research or the research is significantly duplicative in nature. There is also the consideration of "dual-use" research when biological, infectious disease, or biochemical research could be used to harm and whether that research should be performed or even published. The sections on historical perspectives and fetal stem cells approach these types of issues, but further expansion of these topics would be appropriate to distinguish this book from others in this area.
Assessment: This is an interesting read with illustrative cases that is suitable as a guide for a college-level course. However, it should be considered a starting point for ethics discussions. It does not address some of the chronically vexing problems such as the scientific merit of some studies or studies that do not prove what the investigator wanted so they are not published. There are many ethical questions that this book does not cover.
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Product Details

  • ISBN-13: 9780781788175
  • Publisher: Lippincott Williams & Wilkins
  • Publication date: 6/1/2009
  • Edition description: New Edition
  • Pages: 300
  • Sales rank: 275,583
  • Product dimensions: 6.90 (w) x 9.90 (h) x 0.40 (d)

Table of Contents

SECTION I ETHICAL AND REGULATORY BACKGROUND

  • Historical Perspective
  • Ethical Framework for Research
  • Federal Regulations on Human Participants Research
  • IRB Review of Human Participants Research
  • Assessment of Risks and Benefits
  • Informed Consent
  • Confidentiality
  • SECTION II THE RESEARCHER-PARTICIPANT RELATIONSHIP

  • Identification and Recruitment of Participants
  • Payment to Research Participants
  • Responsibility for Incidental Risks
  • Offering Results of Research Tests to Participants
  • SECTION III RESPONSIBLE CONDUCT OF RESEARCH

  • Research Misconduct
  • Authorship and Its Responsibilities
  • Patenting and Commercialization of Discoveries
  • Conflicts of Interest
  • SECTION IV VULNERABLE PARTICIPANTS

  • Persons with Impaired Decision-Making Capacity
  • Research with Children
  • Research with Adolescents
  • Emergency and Intensive Care Research
  • Research with Ethnic and Minority Populations
  • Research with Prisoners
  • Clinical Research in Resource-Poor Countries

    SECTION V ETHICAL ISSUES IN SPECIFIC TYPES OF RESEARCH

  • Research with Existing Data and Biological Materials
  • Observational Studies
  • Translational Research
  • Clinical Trials
  • Genetics, Genomics, and Gene Transfer Research
  • Stem Cell Research
  • INDEX

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